The Ministry of Food and Drug Safety (MFDS), led by Commissioner Yu-kyung Oh, is advancing two major regulatory reforms: clearer data requirements for over-the-counter (OTC) drug submissions and a Phase 3 clinical trial exemption for fixed-dose combinations (FDCs) used in hypertension and dyslipidemia. Both measures stem from extensive discussions within consultative councils launched earlier this year and are drawing strong industry interest.

At a November 25 briefing, the Drug Evaluation Department of the National Institute of Food and Drug Safety Evaluation outlined progress made through the “OTC Drug Development Support Council” and the “Combination Drug Development Support Council,” formed in April. These bodies—comprising MFDS officials, regulatory experts, and pharmaceutical R&D leaders—were convened to identify key regulatory challenges. Their recommendations were incorporated into the MFDS’s “Top 50 Safety and Regulatory Improvement Tasks.”

A central theme of the OTC reform is “clarification.” When companies sought to shift between similar formulations—such as ointment to cream or cream to gel—there was no consistent guideline on what data were required to demonstrate therapeutic equivalence. The MFDS plans to formalize these standards next year to reduce uncertainty.

So-hee Kim, Director of the Cardiovascular and Neurological Drugs Division, noted that companies often struggled to determine the necessary data when submitting products with the same active ingredient, strength, and indication but a different formulation. “By clearly defining these requirements, we will reduce confusion for industry and broaden the scope of data that can be accepted,” she said.

Industry representatives said the MFDS’s clarification effort effectively simplifies the data-submission process.
Sung-woo Jung, Team Leader at Genuone Sciences, explained that companies wanting to move between similar topical forms were required to undertake full therapeutic-equivalence studies, a burden that often discouraged reformulation. “Even with identical active ingredients and strengths, differences in excipients—such as those affecting viscosity—made comparative dissolution testing difficult. The MFDS now intends to ease these requirements, lowering the hurdle for demonstrating therapeutic equivalence,” he said.

Jung added that reduced barriers would allow companies to offer formulations tailored to patient needs—such as ointments for thicker skin or gels for thinner skin—creating more diverse OTC options.

Jung-hee Sung, Director at Bayer Korea, said the initiative “creates a new playing field” beyond traditional manufacturing standards. “Globally, regulators are expanding formulation options to enhance consumer choice. MFDS is moving in that direction, and this opens a meaningful new market,” she said.

Meanwhile, the MFDS plans to finalize a Phase 3 exemption pathway for hypertension–dyslipidemia FDCs by year-end, with implementation expected next year.

Joo-hye Kang, Director General of the Drug Evaluation Department, presented the scientific basis:
“The MFDS conducted a meta-analysis of clinical data generated over the past decade, covering 28 products and roughly 5,000 patients. The analysis confirmed that antihypertensive and lipid-lowering agents do not interfere with each other’s therapeutic effects and pose no safety concerns. Based on these findings and discussions within the consultative body, we determined that a Phase 3 exemption for these FDCs is appropriate.”

Traditionally, manufacturers were required to conduct Phase 3 trials comparing the combination product against each monotherapy control group. Companies have long argued that, because these components are already individually approved, Phase 3 results were predictable unless a major formulation issue existed.

Industry welcomed the MFDS’s decision, calling the meta-analysis a meaningful scientific approach to regulatory relief.
Chan-ho Gil, Head of Development at Sam-A Pharmaceutical, said, “Industry has repeatedly questioned whether Phase 3 trials are truly necessary for combination therapy in comorbid conditions. The MFDS reflected these concerns and applied a scientific method to ease the burden. Considering the substantial costs companies have faced for Phase 3 studies, this marks a major step forward and demonstrates the MFDS’s evolving role.”